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Blood, 15 May 2006, Vol. 107, No. 10, pp. 4177-4181.
Prepublished online as a Blood First Edition Paper on January 31, 2006; DOI 10.1182/blood-2005-12-4851.


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TRANSPLANTATION

Treatment of acute graft-versus-host disease with prednisolone: significant survival advantage for day +5 responders and no advantage for nonresponders receiving anti–thymocyte globulin

Maria Teresa Van Lint, Giuseppe Milone, Salvatore Leotta, Cornelio Uderzo, Rosanna Scimè, Sandro Dallorso, Anna Locasciulli, Stefano Guidi, Nicola Mordini, Simona Sica, Laura Cudillo, Franca Fagioli, Carmine Selleri, Barbara Bruno, William Arcese, Andrea Bacigalupo, for the Gruppo Italiano Trapianto Midollo Osseo (GITMO)

From the Divisione Ematologia 2 Genova San Martino, Genoa; Cattedra di Ematologia Catania, Catania; Clinica Pediatrica Monza, Monza; Divisione Ematologia Ospedale Cervello, Palermo; Medicina IV Ospedale Gaslini Genova, Genoa; Divisione Ematologia, San Camillo Roma, Rome; Cattedra Ematologia, Careggi Firenze, Florence; Divisione Ematologia Cuneo, Cuneo; Cattedra Ematologia, Università Cattolica, Rome; Cattedra Ematologia, Università Tor Vergata Roma, Rome; Clinica Pediatrica Torino, Turin; and Cattedra Ematologica Napoli, Naples, Italy.

Newly diagnosed patients with acute graft-versus-host disease (GvHD, grades I-IV; n = 211) were given 6-methylprednisolone (6MPred) 2 mg/kg per day for 5 consecutive days; 150 patients (71%) tapered 6MPred on day +5 and were considered responders; 61 patients (29%) could not taper their steroid dose and were considered nonresponders. The cumulative incidence of transplant-related mortality (TRM) for responders and nonresponders is, respectively, 27% and 49% (P = .009), and the 5-year survival is 53% and 35% (P = .007). Nonresponders on day +5 (n = 61) were randomized to receive 6MPred 5 mg/kg per day for 10 days alone (n = 34) or in combination with rabbit anti–thymocyte globulin (ATG, 6.25 mg/kg in 10 days; n = 27). The 2 groups were balanced for clinical and GvHD characteristics. One month after randomization, 26% had a complete response; 23%, a partial response; 33%, stable GvHD; 10%, worsened; and 8%, died. There was no significant difference in response, TRM, and survival between the non-ATG and ATG group. In conclusion, 5 days of prednisolone as first-line therapy of acute GvHD identifies patients with different risk of TRM, and second-line therapy with a combination of 6MPred + ATG does not improve patient outcome, compared with 6MPred alone.


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